COVIDOM: Longterm Morbidity of SARS-CoV-2 Infection and COVID-19 Disease - Consequences for Health Status and Quality of Life (NAPKON-POP)

Project description

COVID-19 is a novel disease caused by SARS-CoV-2 that primarily affects the lungs but also various other organs of the body already in early stages of the disease. Due to the multiple organ involvements in the acute phase, it is conceivable that - in a significant proportion of patients - longterm sequels in various organ systems might occur, thereby impacting the individual's health status and quality of life; and posing a relevant burden to the resources of the health care system.

In order to identify and treat these sequelae in a timely fashion and to get a sense of the prevalence of such SARS-CoV-2 sequelae on the population level, it is important to collect follow-up data and to comprehensively re-examine a population-representative sample of SARS-CoV-2 infected individuals. Within the COVIDOM study the investigators will conduct deep clinical and biochemical phenotyping in population-representative samples in Germany. This will allow novel insights into disease pathogenesis and chronicity of virus infections.

Hypotheses:

- Across all severity stages in the acute phase, SARS-CoV-2 infection causes longterm damages in various organ systems in a significant proportion of patients.

- Beyond the damages directly caused by the infection, also the behavioral changes implemented to reduce the spread of the virus might impact an individual's health status and quality of life.

- The infection itself and the pandemic in general results in increased use of health care resources.

Methods:

SARS-CoV-2 infected individuals in defined geographic regions will be contacted through the responsible health authorities and will be informed about the study and invited to participate. These individuals will presumably represent all severity grades in the initial phase of the infection (asymptomatic, uncomplicated, complicated, critical course of disease) and each of them will be offered a detailed clinical examination program that Includes structural and functional assessment of various organ systems (lungs, cardiovascular, CNS including smell/tase, liver), a comprehensive medical history, as well as psychological and psychiatric assessments.

The COVIDOM on-site examination programme comprises additional questionnaires on fatigue (FACIT-F; Canadian Consensus Criteria (CCC) for ME/CFS).

(Description adapted from clinical trial website: see link above)